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Polofil NHT Flow
EUDAMEDClass IIa (EU MDR)
Ref 1113Ref 1115Ref 1114
by VOCO GmbH
Identity
- Trade Name
- Polofil NHT Flow EUDAMED
- Device Name
- Polofil NHT Flow EUDAMED
- Model / Reference
- 1113 EUDAMED1115 EUDAMED1114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E22111131 EUDAMEDE22111151 EUDAMEDE22111141 EUDAMED
- Basic UDI-DI
- ++E2210336000000000DT EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental composite resin
Polofil NHT Flow by VOCO GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E2210336000000000DT | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (3)
- EUDAMED 91c9ab86-b8ed-4c0a-a858-f3f4a3d4155f 61 fields · synced Oct 6, 2026
- EUDAMED 2b03ae78-be6d-459f-8a36-f18bdd4b4760 61 fields · synced Jul 9, 2026
- EUDAMED 869d1cca-4d59-4d27-8ac2-d21488725922 61 fields · synced Jul 18, 2026